
Xintec Corporation
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OPTICA 120 ND:YAG SURGICAL LASER SYSTEM is an FDA 510(k)-cleared medical device (K901710) manufactured by Xintec Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 1990. Regulation: 8.